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Zenith TX2® Post-market Approval Study (TX2 2PAS)

Primary Purpose

Descending Thoracic Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zenith TX2® TAA Endovascular Graft
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Descending Thoracic Aortic Aneurysm focused on measuring Endovascular Aneurysm Repair, Aortic Aneurysm, Thoracic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or
  • Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or
  • Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

  • Age less than 18 years
  • Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
  • Pregnant, breast-feeding, or planning on becoming pregnant within 24 months
  • Unwilling or unable to comply with the follow-up schedule
  • Inability or refusal to give informed consent
  • Simultaneously participating in another investigative device or drug study

Sites / Locations

  • Kaiser Permanente
  • University of Denver Colorado
  • University of Florida
  • Tampa General Hospital
  • Heart Care Midwest
  • Iowa Heart Center
  • University of Massachusetts
  • University of Michigan Hospital
  • Dartmouth Hitchcock Medical Center
  • Cooper University Hospital
  • Hackensack University Medical Center
  • Montefiore Medical Center
  • New York Hospital of Queens
  • North Shore University Hospital
  • New York University
  • Strong Memorial Hospital
  • University of North Carolina
  • Hospital of the University of Pennsylvania
  • Allegheny General Hospital
  • DFW Vascular Group
  • Baylor University Medical Center at Dallas
  • The Heart Hospital Baylor Plano
  • University of Virginia Medical Center
  • Harborview Medical Center
  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular repair

Arm Description

treatment

Outcomes

Primary Outcome Measures

Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2008
Last Updated
May 10, 2021
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00813358
Brief Title
Zenith TX2® Post-market Approval Study
Acronym
TX2 2PAS
Official Title
Zenith TX2® TAA Endovascular Graft Post-approval Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 10, 2009 (undefined)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Research Incorporated

4. Oversight

5. Study Description

Brief Summary
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Descending Thoracic Aortic Aneurysm
Keywords
Endovascular Aneurysm Repair, Aortic Aneurysm, Thoracic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endovascular repair
Arm Type
Experimental
Arm Description
treatment
Intervention Type
Device
Intervention Name(s)
Zenith TX2® TAA Endovascular Graft
Other Intervention Name(s)
TEVAR
Intervention Description
Endovascular treatment with the study device
Primary Outcome Measure Information:
Title
Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
Description
Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter Exclusion Criteria: Age less than 18 years Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years) Pregnant, breast-feeding, or planning on becoming pregnant within 24 months Unwilling or unable to comply with the follow-up schedule Inability or refusal to give informed consent Simultaneously participating in another investigative device or drug study
Facility Information:
Facility Name
Kaiser Permanente
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Denver Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33601
Country
United States
Facility Name
Heart Care Midwest
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York Hospital of Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
DFW Vascular Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Baylor University Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

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Zenith TX2® Post-market Approval Study

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